The Human Subjects Committee (also known as the Institutional Review Board or IRB) assures that risks to human research subjects are minimized, consent is voluntary and informed, and confidentiality is protected. The Committee upholds the principles articulated in the Belmont Report and applies the regulations articulated in the Common Rule.
Determine if you need IRB review
To determine if your study, research, or project requires Committee review, go to QuestionPro and answer a few targeted questions.
If you plan to collect data from SDSU students, know that the university will not send a mass email to all students for a research project. Groups of students may be contacted on an investigator’s behalf through the following channels:
- The Student Association can post links to surveys in the Jackrabbit Report or on MyState.
- Faculty members can email students in their classes.
- Coaches can email student athletes.
- Department heads can email students in their departments.
- Deans can email students in their college.
Training
All researchers conducting human subjects research are required to complete training in the protection of human research participants via CITI Training at www.citiprogram.org. With any questions about CITI Training, review the Training FAQs.
Submit a Proposal
Any research project in which university faculty, staff or students will collect and analyze data on human subjects must be reviewed and approved by the IRB before data collection begins.
To submit a proposal:
1. Download the appropriate form from the list below. Access these forms via SDSU IRB Forms (Box folder) using your SDSU credentials.
- The General Research Form: Use for research with human subjects.
- Secondary Analysis of Data Application: Use if your research involves the use/analysis of existing data or samples that were collected prior to your research project.
2. Visit the SDState InfoReady site, our internal submission platform. Login with your SDSU credentials. Upload forms via Human Subjects Research Application.
3. Complete the basic information then upload the completed application form and all relevant attachments (such as consent forms, survey instrument, etc.).
4. To finalize your application, accept the certification statement and submit.
Amend or Terminate a Project
Submit forms for amendment or termination via SDState InfoReady.
- Protocol Closeout or Termination: Use this form to closeout or terminate a research project that was previously approved by the SDSU IRB. Submit this form after all recruitment, research interventions, and data collection is complete, and all research data has been de-identified.
- Protocol Amendment: Use this form to obtain IRB review and approval for changes to research. Changes to approved research may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to participants. Examples of changes requiring IRB review include but are not limited to changes in investigators or research team members, purpose/scope of research, recruitment procedures, compensation strategy, participant population, research setting, interventions involving participants, data collection procedures, or surveys, measures, or other data forms.
Report a problem
Researchers must report any incident that is unexpected (given the research procedures and population), may have been caused by the procedures involved in the research, and suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized. In addition to adverse events/effects, you should also report any breaches of confidentiality and complaints about the study from subjects or staff.
If any such problem occurs, please take the following action:
- Attend to the safety and care of the research participant(s).
- Consider whether any more participants should be used in the research and consider immediately stopping the study until the occurrence is investigated.
- If the problem is serious (harmful, fatal or life threatening), report the event either orally or in writing to the Research Integrity and Compliance Officer within three days or call 605-688-5051
For all problems, submit the Incident-Complaint form through SDState InfoReady within 10 working days. The Research Integrity and Compliance Officer will review the report to follow up and take appropriate action.